human experimentation

Summary

Summary: The use of humans as investigational subjects.

Top Publications

  1. ncbi Balancing justice and autonomy in clinical research with healthy volunteers
    N E Kass
    Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Berman Institute of Bioethics, Baltimore, Maryland, USA
    Clin Pharmacol Ther 82:219-27. 2007
  2. ncbi Why healthy subjects volunteer for phase I studies and how they perceive their participation?
    Luis Almeida
    Department of Research and Development, BIAL, A Av da Siderurgia Nacional, 4745 457, S Mamede do Coronado, Portugal
    Eur J Clin Pharmacol 63:1085-94. 2007
  3. doi More than the money: a review of the literature examining healthy volunteer motivations
    Leanne Stunkel
    Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
    Contemp Clin Trials 32:342-52. 2011
  4. pmc Principal investigator views of the IRB system
    Simon N Whitney
    Department of Family, Community Medicine, Houston Center for Education, Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098 3926, USA
    Int J Med Sci 5:68-72. 2008
  5. ncbi Safety and clinical outcome of experimental challenge of human volunteers with Plasmodium falciparum-infected mosquitoes: an update
    Judith E Epstein
    Malaria Program, Naval Medical Research Center, Silver Spring, MD, 20910, USA
    J Infect Dis 196:145-54. 2007
  6. pmc An assessment of early diagnosis and treatment of malaria by village health volunteers in the Lao PDR
    Viengvaly Phommanivong
    Institut de Francophonie pour Médecine Tropicale, Vientiane, BP 9519, Lao PDR
    Malar J 9:347. 2010
  7. ncbi Immunotherapy: bewitched, bothered, and bewildered no more
    Ralph M Steinman
    Laboratory of Cellular Physiology and Immunology, Rockefeller University, New York, NY 10021 6399, USA
    Science 305:197-200. 2004
  8. ncbi Moral imperialism and multi-centric clinical trials in peripheral countries
    Volnei Garrafa
    Cátedra UNESCO de Bioética, Universidade de Brasilia, Brasilia, Brasil
    Cad Saude Publica 24:2219-26. 2008
  9. ncbi Assessing benefits in clinical research: why diversity in benefit assessment can be risky
    Larry R Churchill
    Vanderbilt University, USA
    IRB 25:1-8. 2003
  10. ncbi Informed consent for pediatric research: is it really possible?
    Eric Kodish
    J Pediatr 142:89-90. 2003

Research Grants

  1. Lyophilization of Plasmodium falciparum sporozoite vaccine
    Stephen Hoffman; Fiscal Year: 2007
  2. PARP inhibitor therapy for septic shock
    Andrew Salzman; Fiscal Year: 2004
  3. PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONS
    Stanley M Spinola; Fiscal Year: 2010
  4. MODEL OF HYPERCORTISOLISM FOR MAJOR DEPRESSIONS
    Alan Schatzberg; Fiscal Year: 1999
  5. Resistant E.coli in Humans and Poultry
    James Johnson; Fiscal Year: 2005
  6. PHOSPHORYLATION OF CILIARY TARGET PROTEINS
    MATTHIAS A SALATHE; Fiscal Year: 2010
  7. Harmful effects of transfusion of older stored red cells: iron and inflammation
    Steven Spitalnik; Fiscal Year: 2009
  8. MARKERS OF HUMAN INFECTION WITH BOVINE LEUKEMIA VIRUS
    GERTRUDE BUEHRING; Fiscal Year: 2007
  9. IMMUNOCHEMISTRY OF GONOCOCCAL LIPOPOLYSACCHARIDE
    JOHN GRIFFISS; Fiscal Year: 2003
  10. Dietary HDAC Inhibitors in Colon Cancer Prevention
    Roderick H Dashwood; Fiscal Year: 2010

Detail Information

Publications223 found, 100 shown here

  1. ncbi Balancing justice and autonomy in clinical research with healthy volunteers
    N E Kass
    Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Berman Institute of Bioethics, Baltimore, Maryland, USA
    Clin Pharmacol Ther 82:219-27. 2007
    ..Other studies enrolling healthy volunteers often are simply looking for the most scientifically sound population for the study of normal human physiology...
  2. ncbi Why healthy subjects volunteer for phase I studies and how they perceive their participation?
    Luis Almeida
    Department of Research and Development, BIAL, A Av da Siderurgia Nacional, 4745 457, S Mamede do Coronado, Portugal
    Eur J Clin Pharmacol 63:1085-94. 2007
    ..To characterize the motivations and attitudes of healthy subjects who volunteer for phase I studies as well as their perception of the informed consent procedure and participation in the study...
  3. doi More than the money: a review of the literature examining healthy volunteer motivations
    Leanne Stunkel
    Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA
    Contemp Clin Trials 32:342-52. 2011
    ..This study summarized and analyzed existing empirical research on self-reported motivations of healthy volunteers participating in studies not intended to offer benefit from participation...
  4. pmc Principal investigator views of the IRB system
    Simon N Whitney
    Department of Family, Community Medicine, Houston Center for Education, Research on Therapeutics, Baylor College of Medicine, Houston, TX 77098 3926, USA
    Int J Med Sci 5:68-72. 2008
    ..Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits...
  5. ncbi Safety and clinical outcome of experimental challenge of human volunteers with Plasmodium falciparum-infected mosquitoes: an update
    Judith E Epstein
    Malaria Program, Naval Medical Research Center, Silver Spring, MD, 20910, USA
    J Infect Dis 196:145-54. 2007
    ..In 1997, an analysis of experience with 118 volunteers indicated that mosquito inoculation of P. falciparum could be a safe, well-tolerated, reproducible, and efficient method of challenge...
  6. pmc An assessment of early diagnosis and treatment of malaria by village health volunteers in the Lao PDR
    Viengvaly Phommanivong
    Institut de Francophonie pour Médecine Tropicale, Vientiane, BP 9519, Lao PDR
    Malar J 9:347. 2010
    ..Early diagnosis and treatment (EDAT) is crucial to reducing the burden of malaria in low-income countries. In the Lao PDR, this strategy was introduced in 2004-2005 and an assessment was performed at the community level in January 2007...
  7. ncbi Immunotherapy: bewitched, bothered, and bewildered no more
    Ralph M Steinman
    Laboratory of Cellular Physiology and Immunology, Rockefeller University, New York, NY 10021 6399, USA
    Science 305:197-200. 2004
    ..We suggest steps to be taken to reinvigorate basic research in human subjects as part of the mainstream of science...
  8. ncbi Moral imperialism and multi-centric clinical trials in peripheral countries
    Volnei Garrafa
    Cátedra UNESCO de Bioética, Universidade de Brasilia, Brasilia, Brasil
    Cad Saude Publica 24:2219-26. 2008
    ....
  9. ncbi Assessing benefits in clinical research: why diversity in benefit assessment can be risky
    Larry R Churchill
    Vanderbilt University, USA
    IRB 25:1-8. 2003
  10. ncbi Informed consent for pediatric research: is it really possible?
    Eric Kodish
    J Pediatr 142:89-90. 2003
  11. ncbi [Changes in the Declaration of Helsinki: economic fundamentalism, ethical imperialism and social control]
    V Garrafa
    , , , , DF, 70910-900, Brasil
    Cad Saude Publica 17:1489-96. 2001
    ....
  12. ncbi Paying research subjects: an analysis of current policies
    Neal Dickert
    W G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
    Ann Intern Med 136:368-73. 2002
    ..Few data are available on guidelines used by research organizations to make decisions about paying subjects...
  13. ncbi Ethics of medical research in developing countries: the role of international codes of conduct
    J L Hutton
    Department of Statistics, University of Newcastle, Newcastle upon Tyne, UK
    Stat Methods Med Res 9:185-206. 2000
    ..Statisticians share important responsibilities in maintaining ethical medical research in all countries...
  14. ncbi [Regulations, conflicts and ethics of medical research in developing countries]
    Marta Maciel Lyra Cabral
    Departmento de Imunologia, Fundacao Oswaldo Cruz, Recife, PE, Brasil
    Rev Saude Publica 40:521-7. 2006
    ..Therefore, it is necessary to minimize the risk of exploitation of developing countries populations. The present study provides an outlook of ethical protection for human research in developing countries...
  15. doi Clinical trials and healthy volunteers
    Pamela R Ferguson
    University of Dundee, Park Place, Dundee, UK
    Med Law Rev 16:23-51. 2008
  16. doi Views of midwives about ethical aspects of participation in placental perfusion studies
    Arja Halkoaho
    Department of Nursing Science, Faculty of Health Sciences, University of Eastern Finland, 70211 Kuopio, Finland
    Midwifery 28:131-7. 2012
    ..Little is known regarding the role of the midwife in recruiting mothers to participate in scientific research...
  17. ncbi [Ethics and medical research: principles, guidelines, and regulations]
    Euclides Ayres de Castilho
    Departamento de Medicina Preventiva, Faculdade de Medicina, Universidade de Sao Paulo, Av Dr Arnaldo 455, 01246 903 Sao Paulo, SP, Brazil
    Rev Soc Bras Med Trop 38:344-7. 2005
    ....
  18. ncbi Conflicts of interest in research involving human beings
    Dirceu Greco
    School of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil
    J Int Bioethique 19:143-54, 202-3. 2008
    ....
  19. ncbi Human experimentation in developing countries: improving international practices by identifying vulnerable populations and allocating fair benefits
    Kristen Farrell
    University of Maryland School of Law, Baltimore, MD, USA
    J Health Care Law Policy 9:136-61. 2006
  20. doi Ethical aspects in placental perfusion studies: views of the researchers
    A Halkoaho
    University of Eastern Finland
    Placenta 32:511-5. 2011
    ..Thus, continuous effort for better research ethics is essential and requires research on research ethics...
  21. ncbi The age of neuroelectronics
    Adam Keiper
    The New Atlantis, USA
    New Atlantis 11:4-41. 2006
  22. ncbi Experimental malaria in human volunteers: ethical aspects
    H K A Visser
    Neth J Med 63:41-2. 2005
  23. ncbi Justice and the human development approach to international research
    Alex John London
    Carnegie Mellon University, USA
    Hastings Cent Rep 35:24-37. 2005
  24. pmc Evaluation of the safety and immunogenicity of two antigen concentrations of the Mtb72F/AS02(A) candidate tuberculosis vaccine in purified protein derivative-negative adults
    Isabel Leroux-Roels
    Center for Vaccinology, Ghent University Hospital, De Pintelaan 185, B 9000 Ghent, Belgium
    Clin Vaccine Immunol 17:1763-71. 2010
    ..In conclusion, Mtb72F/AS02(A) is clinically well tolerated and is highly immunogenic in TB-naïve adults. The 10- and 40-μg Mtb72F/AS02(A) vaccines show comparable safety and immunogenicity profiles...
  25. ncbi Principles of early stopping of randomized trials for efficacy: a critique of equipoise and an alternative nonexploitation ethical framework
    David Buchanan
    Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
    Kennedy Inst Ethics J 15:161-78. 2005
    ....
  26. ncbi The therapeutic misconception: problems and solutions
    Charles W Lidz
    Department of Psychiatry, University of Massachusetts Medical School, Worcester, Massachusetts, USA
    Med Care 40:V55-63. 2002
    ..The therapeutic misconception is a serious problem for informed consent in clinical research...
  27. ncbi Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast
    C S Molyneux
    Kenya Medical Research Institute, PO Box 230, Kilifi, Kenya
    Soc Sci Med 59:2547-59. 2004
    ..These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere...
  28. ncbi The old faith and the new science: the Nuremberg Code and human experimentation ethics in Britain, 1946-73
    Jenny Hazelgrove
    School of Nursing, University of Nottingham, UK
    Soc Hist Med 15:109-35. 2002
    ..In a similar move, their predecessors had helped to negotiate the Nuremberg Code in anticipation of public criticism of experimentation arising from the Nuremberg Medical Trial...
  29. ncbi Oversight of human participants research: identifying problems to evaluate reform proposals
    Ezekiel J Emanuel
    Department of Clinical Bioethics, Warren G Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland 20892 1156, USA
    Ann Intern Med 141:282-91. 2004
    ....
  30. ncbi Research without consent: current status, 2003
    Michelle H Biros
    Department of Emergency Medicine, Hennepin County Medical Center and the University of Minnesota School of Medicine, 701 Park Avenue South, Minneapolis, MN 55415, USA
    Ann Emerg Med 42:550-64. 2003
    ....
  31. ncbi The dysregulation of human subjects research
    Norman Fost
    JAMA 298:2196-8. 2007
  32. pmc Ethics review for sale? Conflict of interest and commercial research review boards
    T Lemmens
    Faculty of Law, University of Toronto, 78 Queen s Park, Toronto, Ontario, Canada M5S 2C5
    Milbank Q 78:547-84, iii-iv. 2000
    ..The structure of private review tends to breach a core principle of administrative law and procedural justice. Reform of the research review system will reinforce public trust in the process...
  33. ncbi Ethics. Protecting communities in biomedical research
    C Weijer
    Department of Bioethics, Dalhousie University, Halifax, Nova Scotia, B3H 4H7, Canada
    Science 289:1142-4. 2000
    Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the ..
  34. ncbi Human experimentation with Neisseria gonorrhoeae: progress and goals
    M S Cohen
    Department of Medicine, University of North Carolina at Chapel Hill 27599 7030, USA
    J Infect Dis 179:S375-9. 1999
    ..The experimental model has proven to be an efficient means of studying gonococcal infection and focusing vaccine development. In addition, this model should allow vaccines to be tested quickly and efficiently...
  35. ncbi International Genetic Epidemiology Society: commentary on Darkness in El Dorado by Patrick Tierney
    M P Baur
    Department of Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany
    Genet Epidemiol 21:81-104. 2001
    ..Ethical issues about scientific research in primitive populations deserve serious and wide discussion, but the IGES condemns the gross misrepresentation of the facts and demonization of the principal characters in this book...
  36. pmc Ethics in international health research: a perspective from the developing world
    Zulfiqar Ahmed Bhutta
    Department of Paediatrics, The Aga Khan University, Karachi, Pakistan
    Bull World Health Organ 80:114-20. 2002
    ..Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake...
  37. pmc Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, Tanzania
    Edith A M Tarimo
    Division of Global Health, Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden
    PLoS ONE 6:e14619. 2011
    ..The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled...
  38. ncbi Reconstructing exposures from the UK chemical warfare agent human research programme
    Tj Keegan
    Department of Public Health, University of Oxford, Oxford OX7 3LF, UK
    Ann Occup Hyg 51:441-50. 2007
    ..The resulting cohort study has the potential to provide information which will assist in understanding the long-term health impact of chemical warfare agent exposure on these veterans...
  39. pmc Identification of Haemophilus ducreyi genes expressed during human infection
    Margaret E Bauer
    Department of Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN 46202, USA
    Microbiology 154:1152-60. 2008
    ..We identified three genes, lspA1, lspA2 and tadA, known to be required for virulence in humans. This is the first study to broadly define transcripts expressed by H. ducreyi in humans...
  40. doi Exposures recorded for participants in the UK Chemical Warfare Agent Human Research Programme, 1941-1989
    T J Keegan
    Department of Public Health, University of Oxford, OX3 7LF, UK
    Ann Occup Hyg 53:83-97. 2009
    ..The study is part of a programme of epidemiological research initiated in response to service veterans' concerns about possible long-term health effects of their participation...
  41. pmc Human hallucinogen research: guidelines for safety
    Mw Johnson
    Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, School of Medicine, Baltimore, MD, USA
    J Psychopharmacol 22:603-20. 2008
    ..Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science...
  42. ncbi Therapeutic misconception in clinical research: frequency and risk factors
    Paul S Appelbaum
    Department of Psychiatry, University of Massachusetts Medical School, USA
    IRB 26:1-8. 2004
  43. ncbi Vulnerability to influence: a two-way street
    Gail E Henderson
    University of North Carolina School of Medicine, USA
    Am J Bioeth 4:50-2; discussion W32. 2004
  44. pmc Ethical review of health research: a perspective from developing country researchers
    A A Hyder
    Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
    J Med Ethics 30:68-72. 2004
    ....
  45. ncbi Rationalizing risk assessment in human subject research
    Carl H Coleman
    Health Law and Policy Program, Seton Hall Law School, USA
    Ariz Law Rev 46:1-51. 2004
  46. ncbi Is the argument from marginal cases obtuse?
    Daniel A Dombrowski
    Seattle University, Seattle, WA 98122, USA
    J Appl Philos 23:223-32. 2006
    ..The purpose of the present article is to argue that, despite Anderson's and Diamond's nuanced and perceptive treatments of the argument from marginal cases, this argument is not obtuse in either sense of the term...
  47. ncbi The role of institutional review boards in protecting human subjects: are we really ready to fix a broken system?
    Hazel Glenn Beh
    William S Richardson School of Law, University of Hawaii, USA
    Law Psychol Rev 26:1-47. 2002
  48. pmc Pesticide testing in humans: ethics and public policy
    Christopher Oleskey
    Center for Children s Health and the Environment, Box 1043, Mount Sinai School of Medicine, One Gustav L Levy Place, New York, NY 10029, USA
    Environ Health Perspect 112:914-9. 2004
    ..Participants also strongly encouraged active biomonitoring of every pesticide currently in use to track human exposure, particularly in vulnerable populations, and to assess adverse effects on health...
  49. ncbi Are the rules for research with subjects with dementia changing?: views from the field
    Carol B Stocking
    Section of Geriatrics, MacLean Center for Clinical Medical Ethics, Department of Medicine, University of Chicago, IL 60637, USA
    Neurology 61:1649-51. 2003
    ..The real tradeoff between protection and difficulty in conducting research on devastating illnesses needs to be confronted when new regulations in this area are debated...
  50. pmc Human experimentation: a rule gone awry?
    Adrian Burton
    Environ Health Perspect 114:A360-2. 2006
  51. ncbi Establishing risk of human experimentation with drugs: lessons from TGN1412
    M J H Kenter
    Central Committee on Research Involving Human Subjects, The Hague, Netherlands
    Lancet 368:1387-91. 2006
  52. ncbi Is the concept of informed consent applicable to clinical research involving critically ill patients?
    John M Luce
    San Francisco General Hospital, CA, USA
    Crit Care Med 31:S153-60. 2003
    ..Stronger research oversight may be as important as informed consent in protecting patient welfare...
  53. ncbi Recommendations for informed consent forms for critical care clinical trials
    Henry J Silverman
    University of Maryland School of Medicine, Baltimore, MD, USA
    Crit Care Med 33:867-82. 2005
    ..Many subjects enrolled in research studies have a limited understanding of the research to which they consented...
  54. ncbi Clinical outcome of experimental human malaria induced by Plasmodium falciparum-infected mosquitoes
    D F Verhage
    Departments of Medical Microbiology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
    Neth J Med 63:52-8. 2005
    ..The objective of this study was to evaluate infection rates and clinical safety of different protocols for human experimental malaria induced by Plasmodium falciparum-infected mosquitoes...
  55. pmc Beyond informed consent
    Zulfiqar A Bhutta
    Aga Khan University, Karachi 74800, Pakistan
    Bull World Health Organ 82:771-7. 2004
    ..Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings...
  56. ncbi Moving beyond compliance: measuring ethical quality to enhance the oversight of human subjects research
    Holly A Taylor
    Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
    IRB 29:9-14. 2007
  57. pmc Human subjects issues and IRB review in practice-based research
    Leslie E Wolf
    University of California, San Francisco, San Francisco, California 94143 0903, USA
    Ann Fam Med 3:S30-7. 2005
    ..This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research...
  58. ncbi Ethics of innovative surgery: US surgeons' definitions, knowledge, and attitudes
    Angelique M Reitsma
    Center for Biomedical Ethics, University of Virginia, PO Box 800758, Charlottesville, VA 22908 0758, USA
    J Am Coll Surg 200:103-10. 2005
    ..Surgeons were also invited to self-report knowledge about current federal regulations guiding human subject research and rules for informed consent for and IRB review of clinical research...
  59. ncbi Research on the socio-ethical impact of biomarker use and the communication processes in ECNIS NoE and NewGeneris IP
    Birgit Dumez
    Center for Human Genetics, Department of Medicine, University of Leuven, Herestraat 49, 3000 Leuven, Belgium
    Int J Hyg Environ Health 210:263-5. 2007
    ..A harmonized socio-ethical and legal approach not only increases the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of each citizen of the European Union...
  60. pmc Human testing of pesticides: ethical and scientific considerations
    Alan H Lockwood
    Center for PET 115P, VA Western NY Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215, USA
    Am J Public Health 94:1908-16. 2004
    ..An EPA committee that is free from political and financial conflicts of interest should review this practice...
  61. ncbi Challenges of ethical research in resource-poor settings
    B M Dickens
    Faculty of Law, University of Toronto, Toronto, Ontario, Canada
    Int J Gynaecol Obstet 80:79-86. 2003
    ..The structure and functions of research ethics review committees present difficult challenges, but they may be mitigated by enlightened international collaboration...
  62. pmc Bench-to-bedside review: human subjects research--are more standards needed?
    David T Huang
    CRISMA Laboratory, Department of Critical Care Medicine, Department of Emergency Medicine, University of Pittsburgh, 641 Scaife Hall, Pittsburgh, PA 15261, USA
    Crit Care 10:244. 2006
    ..We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine...
  63. ncbi Research ethics and law of healthcare system quality improvement: the conflict of cost containment and quality
    W Andrew Kofke
    Department of Anesthesia, University of Pennsylvania, Philadelphia 19104 4283, USA
    Crit Care Med 31:S143-52. 2003
    ..The ethical and legal foundations exist to support the systematic practice of informing patients of their participation in some types of QI procedures...
  64. ncbi Money for research participation: does in jeopardize informed consent?
    C Grady
    National Institutes of Health, USA
    Am J Bioeth 1:40-4. 2001
    ..An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make...
  65. ncbi Evaluating the quality of informed consent
    Jeremy Sugarman
    Phoebe R Berman Bioethics Institute, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA
    Clin Trials 2:34-41. 2005
    ..Having such means will be important to monitoring consent and testing potential improvements in the consent process...
  66. pmc Ethics review procedures for research in developing countries: a basic presumption of guilt
    Robert H Gilman
    Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, USA
    CMAJ 171:248-9. 2004
  67. ncbi Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury
    Michael K Paasche-Orlow
    Department of Medicine, Boston University School of Medicine, Boston, Massachusetts 02118, USA
    Am J Med 118:175-80. 2005
    ..We hypothesized that informed consent language at U.S. medical schools would be particularly complex and fall short of IOM goals, especially for projects without industry sponsorship...
  68. ncbi Regional ethics organizations for protection of human research participants
    Anne Wood
    School of Law, University of California, Berkeley, Berkeley, California 94720 7200, USA
    Nat Med 10:1283-8. 2004
  69. ncbi Educating researchers: ethics and the protection of human research participants
    Julie Rothstein Rosenbaum
    Yale University School of Medicine, New Haven, CT, USA
    Crit Care Med 31:S161-6. 2003
    ....
  70. pmc Should society allow research ethics boards to be run as for-profit enterprises?
    Ezekiel J Emanuel
    Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, United States
    PLoS Med 3:e309. 2006
    ..Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval...
  71. ncbi The case of Chester M. Southam: research ethics and the limits of professional responsibility
    Beth Aviva Preminger
    Cornell University Joan and Sanford I Weill Medical College, USA
    Pharos Alpha Omega Alpha Honor Med Soc 65:4-9. 2002
  72. ncbi What is a "minor" increase over minimal risk?
    David Wendler
    Department of Clinical Bioethics, National Institutes of Health Clinical Center, Bethesda, MD 20892, USA
    J Pediatr 147:575-8. 2005
  73. ncbi [Clinical trials in developing countries: who should define ethics?]
    F Béréterbide
    Faculte de Medecine, Département de recherche éthique, Universite Paris Sud XI, France
    Bull Soc Pathol Exot 101:102-5. 2008
    ....
  74. ncbi Some questionable premises about research ethics
    Ruth Macklin
    Albert Einstein College of Medicine, USA
    Am J Bioeth 5:29-31; author reply W15-8. 2005
  75. ncbi Subjects or objects? Prisoners and human experimentation
    Barron H Lerner
    Columbia University, New York, USA
    N Engl J Med 356:1806-7. 2007
  76. ncbi Rethinking research ethics
    Rosamond Rhodes
    Mount Sinai School of Medicine
    Am J Bioeth 5:7-28. 2005
    ..These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research...
  77. ncbi Reflections on 'Rethinking research ethics'
    Robert J Levine
    Am J Bioeth 5:1-3; author reply W15-8. 2005
  78. pmc Strangers at the benchside: research ethics consultation
    Mildred K Cho
    Stanford Center for Biomedical Ethics, Center for Integration of Research on Geneticsand Ethics, Palo Alto, CA 94304, USA
    Am J Bioeth 8:4-13. 2008
    ..We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program...
  79. ncbi Response to Athula Sumathipala and Sisira Siribaddana, "Revisiting 'freely given informed consent' in relation to the developing world: the role of an Ombudsman" (AJOB 4:3)
    Bob Simpson
    Am J Bioeth 5:W24-6. 2005
  80. ncbi Ethical considerations in phenomenological research
    Wendy Walker
    School of Health Sciences, University of Birmingham, UK
    Nurse Res 14:36-45. 2007
    ..Wendy Walker examines some important ethical issues that researchers need to consider before and during phenomenological research. She argues that failure to address such issues means putting at risk the rights of research participants...
  81. ncbi Excluding particular information from consent forms
    Neal Dickert
    Department of Health Policy and Management, Phoebe R Berman Bioethics Institute, John Hopkins University Bloomberg School of Public Health, Hampton House 348, 624 N Broadway, Baltimore, MD 21205, USA
    Account Res 12:33-45. 2005
    ..Further, we argue that the regulations ought to be amended to reflect this obligation...
  82. doi Quality-improvement research and informed consent
    Franklin G Miller
    Department of Bioethics, National Institutes of Health, Bethesda, MD, USA
    N Engl J Med 358:765-7. 2008
  83. ncbi Ten questions institutional review boards should ask when reviewing international clinical research protocols
    Daniel W Fitzgerald
    IRB 25:14-8. 2003
  84. doi A plea for pragmatism in clinical research ethics
    David H Brendel
    Harvard Medical School, McLean Hospital, Belmont, MA 02478, USA
    Am J Bioeth 8:24-31. 2008
    ....
  85. ncbi Harming through protection?
    Mary Ann Baily
    Hastings Center, Garrison, NY, USA
    N Engl J Med 358:768-9. 2008
  86. ncbi Human research protections: time for regulatory reform?
    Karen J Maschke
    Hastings Cent Rep 38:19-22. 2008
  87. ncbi How not to rethink research ethics
    Tom L Beauchamp
    Georgetown University, USA
    Am J Bioeth 5:31-3; author reply W15-8. 2005
  88. ncbi The history and moral foundations of human-subject research
    Jeffry Blustein
    Division of Bioethics, Montefiore Medical Center and the Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York 10461, USA
    Am J Phys Med Rehabil 86:82-5. 2007
  89. ncbi Research ethics in Internet-enabled research: human subjects issues and methodological myopia
    Joseph B Walther
    Department of Communication, Cornell University, 336 Kennedy Hall, Ithaca, NY 14853 4203, USA
    Ethics Inf Technol 4:205-16. 2002
    ....
  90. ncbi The limitations of "vulnerability" as a protection for human research participants
    Carol Levine
    United Hospital Fund
    Am J Bioeth 4:44-9. 2004
    ..Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges...
  91. ncbi Undue inducement: the only objection to payment?
    Ari VanderWalde
    UCLA, USA
    Am J Bioeth 5:25-7. 2005
  92. ncbi A quartet of criticisms
    Harold Y Vanderpool
    University of Texas Medical Branch, USA
    Am J Bioeth 5:16-9. 2005
  93. ncbi The welcome reassessment of research ethics: is "undue inducement" suspect?
    Howard Brody
    Michigan State University, USA
    Am J Bioeth 5:15-6. 2005
  94. ncbi Undue inducement: nonsense on stilts?
    Ezekiel J Emanuel
    National Institutes of Health, USA
    Am J Bioeth 5:9-13; discussion W8-11, W17. 2005
  95. ncbi Part I: what is the requirement for data sharing?
    Virginia A de Wolf
    IRB 27:12-6. 2005
  96. ncbi Conflicts of interest in medical research: how much conflict should exceed legal boundaries?
    Kaley Klanica
    Boston University School of Public Health, USA
    J Biolaw Bus 8:37-45. 2005
    ..Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress...
  97. ncbi The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countries
    Somei Kojima
    Asian Center of International Parasite Control, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
    Southeast Asian J Trop Med Public Health 36:728-32. 2005
    ..This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome...
  98. ncbi The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations
    Finnuala Kelleher
    Columbia Journal of Law and Social Problems, Columbia University, USA
    Columbia J Law Soc Probl 38:67-106. 2004
    ....
  99. ncbi Conducting ethical research in pediatrics: a brief historical overview and review of pediatric regulations
    Douglas S Diekema
    University of Washington, Treuman Katz Center for Pediatric Bioethics, Children s Hospital and Regional Medical Center, Seattle, Washington 98101, USA
    J Pediatr 149:S3-11. 2006
    ..Good research is ethical research, and that requires investigators who take seriously the importance of participant welfare, meaningful informed consent, and respect for research participants...
  100. ncbi Beginning anew: same principles, different direction for research ethics
    Mary Simmerling
    University of Chicago, USA
    Am J Bioeth 5:44-6; author reply W15-8. 2005

Research Grants91

  1. Lyophilization of Plasmodium falciparum sporozoite vaccine
    Stephen Hoffman; Fiscal Year: 2007
    ..Additionally, a dried vaccine may accelerate a concerted world-wide effort to eradicate this devastating disease. ..
  2. PARP inhibitor therapy for septic shock
    Andrew Salzman; Fiscal Year: 2004
    ..Based on pre-clinical porcine shock models and clinical safety studies, we expect INO-1001 to be a safe, well-tolerated and effective therapeutic in patients with septic shock. ..
  3. PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONS
    Stanley M Spinola; Fiscal Year: 2010
    ..Chancroid can be treated with only three types of antibiotics. The genes controlled by the stress response systems may prove to be targets of vaccines or alternative treatments for H. ducreyi infection. ..
  4. MODEL OF HYPERCORTISOLISM FOR MAJOR DEPRESSIONS
    Alan Schatzberg; Fiscal Year: 1999
    ....
  5. Resistant E.coli in Humans and Poultry
    James Johnson; Fiscal Year: 2005
    ..Does the research address a current and compelling problem of antimicrobial resistance that is of high public health importance and for which research is needed? [yes]. ..
  6. PHOSPHORYLATION OF CILIARY TARGET PROTEINS
    MATTHIAS A SALATHE; Fiscal Year: 2010
    ..This proposal thus may identify new therapeutic targets that could help to decrease the burden from airway disease exacerbations on individuals and on society. ..
  7. Harmful effects of transfusion of older stored red cells: iron and inflammation
    Steven Spitalnik; Fiscal Year: 2009
    ....
  8. MARKERS OF HUMAN INFECTION WITH BOVINE LEUKEMIA VIRUS
    GERTRUDE BUEHRING; Fiscal Year: 2007
    ....
  9. IMMUNOCHEMISTRY OF GONOCOCCAL LIPOPOLYSACCHARIDE
    JOHN GRIFFISS; Fiscal Year: 2003
    ..Gonococci shed during gonorrhoea make larger LOS. The higher Mr LOS made by MS11mkC - a strain used in human experimentation -have polylactosamine structures...
  10. Dietary HDAC Inhibitors in Colon Cancer Prevention
    Roderick H Dashwood; Fiscal Year: 2010
    ....
  11. Potency of cryopreserved, irradiated sporozoite vaccine
    Stephen Hoffman; Fiscal Year: 2005
    ..The project will also provide a method for cryopreserving unirradiated sporozoites that could be used to challenge volunteers by injection with P. falciparum in vaccine studies worldwide. ..
  12. Genetically Attenuated Malaria Sporozote Vaccine
    Stephen Hoffman; Fiscal Year: 2007
    ..Success in this project has the potential to lead to development of a safe, effective, attenuated malaria vaccine. ..
  13. Imaging Cytolytic T Cells in Cancer Patients Using PET Reporter Genes/Reporter Pr
    Sanjiv S Gambhir; Fiscal Year: 2010
    ..Here, we propose non-invasive imaging of therapeutic immune cells that will be infused into patients with glioma brain tumors and have been shown to kill glioma brain tumor cells. ..
  14. Gene-engineered dendritic cell therapy for diabetics
    Massimo Trucco; Fiscal Year: 2006
    ..The ultimate result could include less intensive or even a complete cessation of insulin replacement therapy in newly-diagnosed diabetics as well as, perhaps, a means of preventing diabetes. ..
  15. Inhalation Dosimetry/Exposure Index of Fiber Aerosol
    Yung Sung Cheng; Fiscal Year: 2006
    ..Sampling devices based on this size-selection definition can be developed in the future for improved assessment of worker exposure. ..
  16. SEVERE PERIODONTITIS AS A RHEOLOGIC MODIFIER
    STEVEN ENGEBRETSON; Fiscal Year: 2003
    ..Dr. Engebretson will receive training in research methodology and molecular biology in order to explore the mechanisms of periodontal medicine through the conduct of human clinical studies as a career goal. ..
  17. Translation Research in Plasmodium vivax
    Socrates Herrera; Fiscal Year: 2005
    ..abstract_text> ..
  18. An ACE Inhibitor as a Treatment for Methamphetamine Dependence
    THOMAS FREDERICK NEWTON; Fiscal Year: 2010
    ..A separate human laboratory study will examine the dose-dependent effects of perindopril on MA- induced craving, though these participants will not take part in the clinical trial. ..
  19. An ACE Inhibitor as a Treatment for Methamphetamine Dependence
    Thomas Newton; Fiscal Year: 2009
    ..A separate human laboratory study will examine the dose-dependent effects of perindopril on MA- induced craving, though these participants will not take part in the clinical trial. ..
  20. Immune function and the progression to type 1 diabetes
    Mark Atkinson; Fiscal Year: 2007
    ....
  21. Role of Leptin in the Neuroendocrine Response to Fasting
    Christos Mantzoros; Fiscal Year: 2004
    ....
  22. PH CONTROL OF PROTEIN SYNTHESIS
    Peter Garlick; Fiscal Year: 2003
    ..abstract_text> ..
  23. PATHOGENESIS OF HAEMOPHILUS DUCREYI INFECTIONS
    STANLEY SPINOLA; Fiscal Year: 1999
    ....
  24. Dietary HDAC Inhibitors in Colon Cancer Prevention
    Roderick Dashwood; Fiscal Year: 2009
    ....